Company Description
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Key Responsibilities
• Responsible for design, analysis and reporting of clinical trials and other scientific research studies.
• Develop protocols, statistical analysis plans, and/or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation with details for programming implementation.
• Implement statistical methodology in scientific investigations.
• Identify scientifically appropriate data collection instruments.
• Identify and report data issues or violations of study assumptions.
• Provide programming specifications for derived variables and analysis datasets.
• Partner with Data Science in preparing for database lock.
• Perform statistical analyses per the analysis plan.
• Collaborate with Statistical Programming to ensure the delivery of high-quality outputs according to timelines.
• Conduct experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming .
• Identify and anticipate issues in the study design, and conduct and propose scientifically sound approaches.
• Evaluate appropriateness of available software for planned analyses and assess needs for potential development of novel statistical methodology.
• Perform statistical analyses including, but not limited to, ANOVA, statistics inferences, survival analysis, logistic regression, linear regression, and categorical data analysis.
• Develop strategy for data presentation and inference. Collaborate in publication of scientific research.
• Ensure accuracy and internal consistency of reports and publications, including tables, listings, and figures.
• Ensure that study results and conclusions are scientifically sound, clearly presented, and consistent with statistical analyses provided.
• Collaborate with multifunction teams.
• Clearly explain statistical concepts to non-statisticians.
• Provide responses to questions, and pursue analyses suggested by data.
• Support communications between assigned product teams and functional management.
• Build/drive cross-functional relationships and collaboration.
• Collaborate with cross functional team for benefit-risk planning and assessment.
• Contribute to cross-functional development of output specifications to address both preplanned safety analyses and ad hoc requests.
• Develop analysis datasets and perform statistical analyses to ensure that protocol objectives are achieved.
• Collaborate/lead within the Safety Statistics Group to implement strategic initiatives that address processes related to interpreting, monitoring, assessing, and reporting safety data to characterize the safety profile of products, improve efficiencies, and provide consistency across therapeutic areas.
• Collaborate with GMA, Clinical Statistics, Data Sciences, Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to identify fit-for-purpose data sources to address research questions, and develop detailed and actionable analysis plans for evidence generation to deliver high quality, patient-centric evidence and insights to drive decisions.
Qualifications
Must possess a PhD degree or foreign academic equivalent in Statistics, Biostatistics, Mathematics, or a highly related field of study with an academic or industrial background in:
• experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming;
• performing statistical analyses including, but not limited to, ANOVA, statistics inferences, survival analysis, logistic regression, linear regression, and categorical data analysis; and
• developing analysis datasets and performing statistical analyses to ensure that protocol objectives are achieved.
Apply online at https://careers.abbvie.com/en. Refer to Req ID: REF26523R.
Additional Information
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term and long-term incentive programs.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
Tagged as: Manager